Kodak Ektascan Storage Phosphor Reader Model 1A

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K913354 ↗

FDA Product Code

IXW

Device Class

Class II

Regulation

21 CFR Part 892.1900

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Kodak Surecell Hcg Urine Test, Modification

  Class II

  FDA 510(k) K936287 Active Cleared 8 Apr 1994

• Kodak Ektaspeed Dental X-Ray Film

  Class I

  FDA 510(k) K800901 Active Cleared 20 May 1980

• Kodak X-Omat 3000 Ra Processor

  Class II

  FDA 510(k) K951396 Active Cleared 15 May 1995

• Kodak X-Omat M43A, M43, & Clinic 1 Processors

  Class II

  FDA 510(k) K934350 Active Cleared 21 Mar 1994

• Amerlite Prolactin-30 Assay

  Class I

  FDA 510(k) K922170 Active Cleared 2 Sep 1992

• Trophypan C with Orthoimaging/Omsimaging Accessory

  Class II

  FDA 510(k) K040556 Active Cleared 7 Apr 2004

See all devices from Eastman Kodak Company →

• What is the Kodak Ektascan Storage Phosphor Reader Model 1A used for?

  The Kodak Ektascan Storage Phosphor Reader Model 1A converts latent image data stored in storage phosphor imaging plates into digital signals. This enables radiologic workflows that rely on computed radiography systems, effectively bridging analog radiographic film with digital diagnostic imaging. It is specifically designed for radiology departments and clinical settings where computed radiography is utilized.

• Is the Kodak Ektascan Storage Phosphor Reader Model 1A a single-use or reusable device?

  The Kodak Ektascan Storage Phosphor Reader Model 1A is a reusable device. It is not intended for single-use and requires regular maintenance and calibration to ensure accurate image acquisition and sustained performance. Proper upkeep is essential for preserving functionality and image quality over time.

• What regulatory approval does the Kodak Ektascan Storage Phosphor Reader Model 1A hold?

  The Kodak Ektascan Storage Phosphor Reader Model 1A holds an FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent by the Radiology Advisory Committee. This clearance was granted on September 4, 1991, with the clearance number K913354. The device falls under Product Code IXW and is classified as a Class II medical device.

• How should the Kodak Ektascan Storage Phosphor Reader Model 1A be stored and handled?

  The Kodak Ektascan Storage Phosphor Reader Model 1A should be stored and handled according to the manufacturer’s guidelines to maintain its functionality and ensure high-quality image output. Proper storage conditions help prevent damage to the device and the storage phosphor plates it processes. Follow the manufacturer’s instructions for calibration, maintenance, and environmental considerations to optimize performance.

• Is the Kodak Ektascan Storage Phosphor Reader Model 1A MRI-safe?

  The provided documentation does not explicitly state whether the Kodak Ektascan Storage Phosphor Reader Model 1A is MRI-safe. If MRI compatibility is a requirement for your clinical setting, consult the manufacturer’s instructions or contact Eastman Kodak Company directly for detailed information on safe usage in MRI environments.